Study of BMS-477118 as Monotherapy With Titration in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00316082
First received: April 18, 2006
Last updated: June 4, 2014
Last verified: June 2014

April 18, 2006
June 4, 2014
June 2006
November 2007   (final data collection date for primary outcome measure)
Change From Baseline in Hemoglobin A1 (A1C) at Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
Mean change from baseline in A1C at Week 24, adjusted for baseline value.
Mean reduction in baseline A1C values after 24 weeks of treatment.
Complete list of historical versions of study NCT00316082 on ClinicalTrials.gov Archive Site
  • Change From Baseline in A1C at Week 24 - Saxagliptin 5 mg QPM [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    Mean change from baseline in A1C at Week 24, adjusted for baseline value.
  • Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    Mean change from baseline in FPG at Week 24, adjusted for baseline value.
  • Percentage of Participants Achieving A1C < 7% at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Percentage of participants achieving A1C < 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin versus placebo at Week 24.
  • Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjusted for baseline value.
  • Change from baseline in fasting plasma glucose.
  • Proportion of subjects achieving A1C < 7%.
  • Change from baseline in area under the curve for postprandial glucose response to an oral glucose tolerance test.
Not Provided
Not Provided
 
Study of BMS-477118 as Monotherapy With Titration in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin as Monotherapy With Titration in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise

The purpose of this trial is to understand if saxagliptin is more effective than placebo as a treatment for type 2 diabetic subjects who are not controlled with diet and exercise

All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to enter the long-term treatment extension period where they will receive metformin (rescue medication) added onto their blinded study medication

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes
  • Drug: Saxagliptin
    Coated tablets, Oral, 2.5 mg, QAM, Daily (6 months ST, 12 months LT)
    Other Name: BMS-477118
  • Drug: Saxagliptin
    Coated tablets, Oral, 2.5 mg titrated to 5mg, QAM, Daily (6 months ST, 12 months LT)
    Other Name: BMS-477118
  • Drug: Saxagliptin
    Coated tablets, Oral, 5mg, QAM, Daily, (6 months ST, 12 months LT)
    Other Name: BMS-477118
  • Drug: Saxagliptin
    Coated tablets, Oral, 5mg QPM, Daily (6 months ST, 12 months LT)
    Other Name: BMS-477118
  • Drug: Placebo
    Coated tablets, Oral, 0mg, Daily (6 months ST, 12 months LT)
  • Drug: metformin
    Tablets, Oral, 500-2000 mg, as needed (12 months LT)
  • Experimental: Saxagliptin 2.5 mg QAM (A)
    PLUS open-label metformin (as needed as rescue medication)
    Interventions:
    • Drug: Saxagliptin
    • Drug: metformin
  • Experimental: Saxagliptin 2.5 mg titrated to 5 mg QAM (B)
    PLUS open-label metformin (as needed as rescue medication)
    Interventions:
    • Drug: Saxagliptin
    • Drug: metformin
  • Experimental: Saxagliptin 5 mg QAM (C)
    PLUS open-label metformin (as needed as rescue medication)
    Interventions:
    • Drug: Saxagliptin
    • Drug: metformin
  • Experimental: Saxagliptin 5 mg QPM (D)
    PLUS open-label metformin (as needed as rescue medication)
    Interventions:
    • Drug: Saxagliptin
    • Drug: metformin
  • Placebo Comparator: Placebo (E)
    PLUS open-label metformin (as needed as rescue medication)
    Interventions:
    • Drug: Placebo
    • Drug: metformin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
365
November 2008
November 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 diabetes
  • Inadequate blood sugar control

Exclusion Criteria:

  • Previous treatment for diabetes
  • Current treatment with other medications to lower blood sugar
  • Major heart, liver or kidney problems
  • Women who are pregnant or breastfeeding
Both
18 Years to 77 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   India,   Russian Federation,   Taiwan
 
NCT00316082
CV181-038
Not Provided
Study Director, Bristol-Myers Squibb
AstraZeneca
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
AstraZeneca
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP